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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, surgical, instrument
Regulation Description Manual surgical instrument for general use.
Product CodeFSM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 90 90
2017 132 132
2018 104 104
2019 168 168
2020 148 148
2021 112 112

Device Problems MDRs with this Device Problem Events in those MDRs
Break 222 222
Peeled/Delaminated 138 138
Delamination 98 98
Naturally Worn 55 55
Crack 52 52
Material Twisted/Bent 44 44
Adverse Event Without Identified Device or Use Problem 32 32
Appropriate Term/Code Not Available 26 26
Contamination /Decontamination Problem 21 21
Material Discolored 17 17
Tear, Rip or Hole in Device Packaging 16 16
Incorrect Measurement 15 15
Component Missing 14 14
Material Fragmentation 13 13
Device Packaging Compromised 13 13
Flaked 10 10
Scratched Material 9 9
Corroded 8 8
Unsealed Device Packaging 8 8
Patient-Device Incompatibility 7 7
Device Contamination with Chemical or Other Material 7 7
Material Integrity Problem 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Material Deformation 6 6
Packaging Problem 6 6
Device Operates Differently Than Expected 6 6
Defective Device 5 5
Dull, Blunt 5 5
Device Damaged Prior to Use 5 5
Defective Component 5 5
Device-Device Incompatibility 4 4
Mechanical Problem 4 4
Loss of or Failure to Bond 4 4
Torn Material 4 4
Detachment of Device or Device Component 4 4
Hole In Material 3 3
Fracture 3 3
Overheating of Device 3 3
Failure to Align 3 3
Difficult to Remove 3 3
Device Displays Incorrect Message 3 3
Residue After Decontamination 3 3
Connection Problem 3 3
Loose or Intermittent Connection 3 3
Detachment Of Device Component 3 3
Coagulation in Device or Device Ingredient 2 2
Delivered as Unsterile Product 2 2
Product Quality Problem 2 2
Device Inoperable 2 2
Sharp Edges 2 2
Material Separation 2 2
Sparking 2 2
Bent 2 2
Device Reprocessing Problem 2 2
Physical Property Issue 2 2
Mechanical Jam 2 2
Material Split, Cut or Torn 2 2
Illegible Information 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Open or Close 1 1
Environmental Compatibility Problem 1 1
Positioning Failure 1 1
Electromagnetic Interference 1 1
Failure to Deliver Energy 1 1
Fluid Leak 1 1
Inadequate Instructions for Healthcare Professional 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Component or Accessory Incompatibility 1 1
Physical Resistance 1 1
Particulates 1 1
Material Puncture/Hole 1 1
Device Slipped 1 1
Problem with Sterilization 1 1
Metal Shedding Debris 1 1
Microbial Contamination of Device 1 1
Device Issue 1 1
Incorrect Or Inadequate Test Results 1 1
Structural Problem 1 1
Device Fell 1 1
Output below Specifications 1 1
Vibration 1 1
Fitting Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination With Biological Material 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Markings/Labelling Problem 1 1
Difficult to Advance 1 1
Incorrect Device Or Component Shipped 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Moisture Damage 1 1
Failure To Adhere Or Bond 1 1
Contamination 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 307 307
No Known Impact Or Consequence To Patient 162 162
No Clinical Signs, Symptoms or Conditions 118 118
No Patient Involvement 60 60
No Information 45 45
No Code Available 25 25
Not Applicable 16 16
Pain 10 10
Foreign Body In Patient 6 6
Device Embedded In Tissue or Plaque 5 5
Laceration(s) 5 5
Insufficient Information 4 4
Injury 3 3
Wound Dehiscence 3 3
Failure of Implant 3 3
Bone Fracture(s) 2 2
Hematoma 1 1
Hemolysis 1 1
Unspecified Infection 1 1
Bradycardia 1 1
Burn(s) 1 1
Cataract 1 1
Death 1 1
Non-union Bone Fracture 1 1
Reaction 1 1
Post Operative Wound Infection 1 1
Blood Loss 1 1
Nerve Damage 1 1
Retinal Injury 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables II Dec-22-2016
2 Synthes (USA) Products LLC II Jun-15-2018
3 Synthes (USA) Products LLC II Dec-21-2016
4 Zimmer Biomet, Inc. II Jul-12-2019
5 Zimmer Biomet, Inc. II Jan-14-2019
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